April 09, 2021
3 min read
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Cobry does not report any relevant financial information. In the study you will find all relevant financial information from all other authors.
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Children with type 1 diabetes who use a hybrid closed-loop system and their parents do not report an increase in diabetes-related exposure compared to children who use a sensor-based insulin pump, according to study data.
Erin C. Cobry
Erin C. Cobry, MD, an assistant professor of pediatrics at the Barbara Davis Center for Childhood Diabetes, University of Colorado Anschutz Medical Campus, and colleagues did not observe any significant differences in hypoglycemia anxiety, diabetes-related stress, and other self-reported results for study participants taking at: slim X2 used insulin pumps with Control-IQ (Tandem Diabetes Care) technology compared to participants who use their own insulin pump or an included t: slim X2 insulin pump with predictive function for suspending glucose.
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“Advances in diabetes therapies offer opportunities to improve diabetes outcomes and reduce long-term complications. However, these advances cannot come at the expense of the child’s and family’s quality of life, ”Cobry told Healio. “It is therefore very important that ease of use and quality of life are part of the evaluation of novel therapies for type 1 diabetes. The results of this study show that hybrid closed-loop systems can be used successfully to improve blood sugar levels without placing greater stress on children with type 1 diabetes or their parents. “
The researchers conducted an open-label randomized clinical trial in four pediatric diabetes centers in the United States. A total of 101 children aged 6 to 13 years with type 1 diabetes for at least 1 year who weighed 25 kg to 140 kg and had a total daily insulin requirement of at least 10 U per day were recruited for each child along with a parent. The participants were randomly assigned to a closed-loop group using the t: slim X2 insulin pump with Control-IQ (n = 78) or a sensor-based pump group (n = 23). Both groups used the Dexcom G6 continuous glucose monitor. The study lasted 16 weeks, after which all participants used the t: slim X2 insulin pump with Control-IQ for an additional 12-week extension phase.
Participants completed a series of questionnaires at the start of the study, after 16 weeks at the end of the study, and after 28 weeks after the extension period had expired. Both parents and children completed the Pediatric Hypoglycemia Fear Survey, Diabetes Problem Areas Survey, Pediatric Quality of Life Survey, and Insulin Delivery Systems Questionnaire: Perceptions, Ideas, Reflections, and Expectations. Parents also completed the Pittsburgh Sleep Quality Index.
Results similar between groups
After 16 weeks there was no significant difference in the self-reported questionnaire values between the closed and the sensor-based pump group. The closed-loop group reported less fear of hypoglycaemia, less diabetes-related stress and a better quality of life after 16 weeks compared to baseline. The parents in the closed-loop cohort also reported a decrease in sleep disorders from baseline to 16 weeks.
“We were surprised that we did not see any significant improvements in patient-reported results after switching to the hybrid closed-loop system,” said Cobry. “However, this was likely due to the small sample size of the control group, as this study was not conducted on the basis of the survey measures.”
During the extension phase, the sensor-based pump group had no significant changes in the questionnaire values. After 28 weeks, the participants in the closed-loop group had similar results in the questionnaires as after 16 weeks. When comparing the change in scores from baseline to 28 weeks, the closed-loop participants had a significant decrease in their total score on the Pediatric Hypoglycemia Anxiety Survey, as well as a decrease in the subscales for worry, avoidance, helplessness, and social consequences. There were also improvements in the overall child quality of life questionnaire score, as well as in the diabetes and communication subscales for the closed-loop group.
More research needed
The researchers wrote that the families participating in the study were likely heavily involved with their child’s diabetes management and were able to take advantage of the new diabetes technology based on previous experience. They suggested that future studies focus on families facing barriers as well as families who are not using technology to manage diabetes.
“This study compared the control group to a group of adolescents using diabetes technology, and therefore was not compared to adolescents who are not using technology to manage diabetes,” the researchers wrote. “This may have affected the ability to see significant changes in the results reported by individuals as all study participants were using diabetic devices. While this was the largest study of closed-loop hybrid use in children with type 1 diabetes and the longest study of continued use, more research is clearly needed in more general populations. “
For more informations:
Erin Cobry, MDcan be reached at erin.cobry@cuanschutz.edu.
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